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001-es BibID:	BIBFORM036727
Első szerző:	Gluud, Christian
Cím:	Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries / Christian Gluud, Christine Kubiak, Kate Whitfield, Jane Byrne, Karl-Heinz Huemer, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Fernando de Andres, Nuria Sanz, German Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes-Mainard
Dátum:	2012
ISSN:	1745-6215
Megjegyzések:	Background In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Results Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. Conclusion The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Trials (electronic resources). - 13 : 27 (2012), p. 1-8. -
További szerzők:	Kubiak, Christine Whitfield, Kate Byrne, Jane Huemer, Karl-Heinz Thirstrup, Steffen Libersa, Christian Barraud, Béatrice Grählert, Xina Dreier, Gabriele Geismann, Sebastian Kuchinke, Wolfgang Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Andres-Trelles, Fernando de Sanz, Nuria Kreis, German Asker-Hagelberg, Charlotte Johansson, Hanna Bourne, Sue Asghar, Adeeba Husson, Jean-Marc Demotes-Mainard, Jacques Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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001-es BibID:	BIBFORM036729
035-os BibID:	PMID:19835581
Első szerző:	Kubiak, Christine
Cím:	Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN) / Christine Kubiak, Fernando de Andres-Trelles, Wolfgang Kuchinke, Karl-Heinz Huemer, Steffen Thirstrup, Kate Whitfield, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Ruth Grychtol, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Nuria Sanz, Raquel Hernandez, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Jane Byrne, Adeeba Asghar, Jean-Marc Husson, Christian Gluud, Jacques Demotes-Mainard
Dátum:	2009
ISSN:	1745-6215
Megjegyzések:	BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. CONCLUSION: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Trials (electronic resources). - 10 : 95 (2009), p. 1-7. -
További szerzők:	Andres-Trelles, Fernando de Kuchinke, Wolfgang Huemer, Karl-Heinz Thirstrup, Steffen Whitfield, Kate Libersa, Christian Barraud, Béatrice Grählert, Xina Dreier, Gabriele Grychtol, Ruth Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Sanz, Nuria Hernandez, Raquel Asker-Hagelberg, Charlotte Johansson, Hanna Bourne, Sue Byrne, Jane Asghar, Adeeba Husson, Jean-Marc Gluud, Christian Demotes-Mainard, Jacques Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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